药物警戒数据挖掘方法比较及其在中成药预警中的应用  

Pharmacovigilance of major parmaceutical innovation

作　　者：向永洋[1] 谢雁鸣[2] 易丹辉[1] 

机构地区：[1]中国人民大学统计学院,北京100872 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2011年第20期2831-2835,共5页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133);国家中医药管理局青年基金项目(06-07JQ11)

摘　　要：国际上"药物警戒"技术方法现在正处于不断完善的阶段,也是药品上市再评价的重要组成部分。本研究旨在探索适合中国国情的中药上市后的安全性检测技术。从20世纪70年代开始,国际上首次出现针对药物警戒的数据挖掘技术,该文尝试挖掘潜在的"药物警戒"信号。为重大创制药上市再评价、再注册制度的建立提供技术支撑。对比各国现有的"药物警戒"信号检测方法 ,各国现有的信号检测方法都是建立不良反应报告数据库,问题的本质在于药物警戒问题可与通过很多假设来转化为统计问题,不同的假设对应不同的统计检验方法,时下各国均是通过传统的四格表比例失衡来检测药物预警信号。信号检测方法国际上尚没有金标准,方法有荷兰(ROR),英国(PRR),WHO(IC),美国食品药品管理局(EBS)等。该文首先通过数据模拟对比以上4种方法,从特异度、样本量需求等角度分析4种方法的优劣点和适用条件,并尝试从技术角度提出新的信号检测方法,如分层贝叶斯(Hierarchical Bayesian)。With the continuous improvement of international ＂pharmacovigilance＂ technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70＇s,for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands （ROR） ,the proportion of reports than the UK ratio （PRR） ,WHO＇s information points （IC）,the U.S. Food and Drug Administration empirical Bayes （EBS）, etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity,the sample size demand,this issue views the advantages and disadvantages of four methods and application conditions, and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.

关 键 词：药物警戒 数据挖掘 

分 类 号：R286[医药卫生—中药学] F426.72[医药卫生—中医学]